Active Ingredient(S)
Ethanol 80% v/v
Banitore Alcohol Hand Rub
FDA Label NDC 56084-031
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhejiang Rifeshow Cosmetics Co., Ltd. for the product Banitore Alcohol Hand Rub (NDC 56084-031). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, otc - stop use, do not use, directions, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use
- Hand Rub to help reduce bacteria that potentially can cause disease.
- For use when soap and water are not available.
Warnings
- For external use only.
- Flammable. Keep away from heat or flame.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Do Not Use
- in children less than 2 months of age.
- on open skin wounds.
Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other Information
- Store between 15-30℃（59-86℉）.
- Avoid freezing and excessive heat above 40℃（104℉）.
Inactive Ingredients
purified water, glycerin, hydrogen peroxide.
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes througthly with water.
Package Label - Principal Display Panel
500ml Label (500ml Label)
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